規制動向
FDA、EMA、TGA および世界の規制動向
規制動向
2026年8月25日•1分で読めます
MHRA Issues Guidance for Reporting Adverse Incidents with Diabetes Management Equipment
The MHRA urges healthcare professionals to support new guidance on reporting suspected adverse incidents related to insulin pumps and CGM devices.
規制動向
2026年8月25日•1分で読めます
MHRA reminds HCPs to discuss GLP‑1RA side effects with patients
Healthcare professionals should inform patients of common and serious side effects of GLP‑1 receptor agonists.
規制動向
2026年8月24日•1分で読めます
FDA Recall: Foreign Substances and Heavy Metals Detected in Product
FDA has recalled a product after routine stability testing revealed visible foreign substances, including heavy metals such as chromium and titanium, and inactive components.
規制動向
2026年8月24日•1分で読めます
MHRA Issues October 2024 Drug Safety Update to Healthcare Professionals
The MHRA released a summary of letters and notifications regarding medicines and medical devices sent to healthcare professionals in October 2024.
規制動向
2026年8月24日•1分で読めます
MHRA Publishes Summary of Recent Medicine and Device Safety Notices
The MHRA has released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
規制動向
2026年8月24日•1分で読めます
FDA Approves ANDA078070 for Valacyclovir Hydrochloride Tablets by Pharmobedient
The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.
規制動向
2026年8月24日•1分で読めます
FDA Approves Padagis Israel’s Desoximetasone 0.25% Topical Ointment (ANDA077770)
The FDA granted approval (ANDA077770) for Padagis Israel’s prescription topical ointment containing 0.25% desoximetasone.
規制動向
2026年8月24日•1分で読めます
FDA Approves Ondansetron Injectable (ANDA077473)
The FDA has approved ANDA077473 for ondansetron injectable, manufactured by Hospira, for intramuscular and intravenous use.
規制動向
2026年8月24日•1分で読めます
FDA Identifies GMP Violations Affecting Sterility Assurance
An FDA inspection uncovered GMP violations that may compromise product sterility and quality, prompting a recall.
規制動向
2026年8月24日•1分で読めます
FDA Recall: CGMP Deviations Due to Intermittent Temperature Excursions
The FDA has issued a recall citing CGMP deviations caused by intermittent temperature excursions during storage.
規制動向
2026年8月24日•1分で読めます
Label Mix-up: Amantadine Capsules Contain Cyclobenzaprine Tablets
FDA recall (D-1035-2017) reports cartons labeled as Amantadine HCl 100 mg capsules actually contain Cyclobenzaprine HCl 5 mg tablets due to a labeling error.
規制動向
2026年8月24日•1分で読めます
MHRA Issues Summary of Recent Medicine and Device Safety Letters (Dec 2024)
The MHRA released a summary of letters and notifications sent to healthcare professionals about medicines and medical devices in December 2024.